40 results · 18ms · Sources: EU EUDAMED, US FDA

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·ML8 CORONARY STENT SYSTEMS

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval
FDA Class 3 ·MLI 1000 ND:YAG OP LASER

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE-M (LN 6L23)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE-M (LN 6L23)

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE-M (LN 6L23)

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION AND ML8 CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION AND ML8 CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION & ML8 CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval
FDA Class 3 ·ARCHITECT CORE-M (LN 6l23), Calibrators, Controls and Reagent Kit

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX ML-8

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX; ML-8

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval
FDA Class 3 ·VH8500 HYPERTHERMIA TREATMENT SYSTEM

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval
FDA Class 3 ·VOL. HYPERTHERMIA TREATMENT SYSTEM MODAL VH8500

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval
FDA Class 3 ·VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval
FDA Class 3 ·VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500

Applicator, Hyperthermia, Interstitial

FDA Pre-Market Approval
FDA Class 3 ·VOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500